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GUIDANCE DOCUMENT

Guidance for Industry: Action Level for Inorganic Arsenic in Apple Juice June 2023

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2012-D-0322
Issued by:
Guidance Issuing Office
Human Foods Program

This guidance provides information to manufacturers on the action level of 10 parts per billion (ppb) or 10 micrograms/kilogram (µg/kg) for inorganic arsenic in apple juice that is intended to help protect public health by reducing exposure to inorganic arsenic and that is achievable by industry with the use of current good manufacturing practices. This guidance presents the background and rationale for FDA’s action level.

Consistent with 21 CFR 109.6(d), this action level reflects the level of inorganic arsenic at which FDA may regard apple juice as adulterated within the meaning of section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 342(a)(1)). We intend to consider this action level, in addition to other factors, such as our confidence in a measured analytical value, when considering whether to bring enforcement action in a particular case.

In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required.

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All written comments should be identified with this document's docket number: FDA-2012-D-0322.

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